510(k) K140846
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 25, 2014
- Date Received
- April 3, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cleanser, Root Canal
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type